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NCT06251232: DILICORT

Proof-of-concept to Evaluate the Efficacy and Safety of Prednisone in Idiosyncratic Hepatotoxicity

Not yet recruiting Phase 2 Last updated 5 April 2024
What this trial tests

Phase 2 trial testing Prednisone in Hepatotoxicity in 60 participants. Not yet recruiting.

Timeline
1 May 2024
Primary endpoint
31 December 2027
31 December 2028

Quick facts

Lead sponsorFundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
PhasePhase 2
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment60
Start date1 May 2024
Primary completion31 December 2027
Estimated completion31 December 2028

Drugs / interventions tested

Conditions studied

Sponsor

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud — full company profile →

Who can join

18 and older, any sex, with Hepatotoxicity or Idiosyncratic Drug Effect. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This trial´s aim is to assess if oral prednisone (compared to placebo), administered over five weeks is beneficial in terms of decreased total bilirubin (TBL): reduction of the peak of TBL at least 50% at 14 days or reduction in the time to normalisation of TBL value.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of Prednisone

Trials testing the same drug.

Other recruiting trials for Hepatotoxicity

Currently open trials in the same condition.

Other Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06251232.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing